關於bevacizumab(Avastin®)處方指引的最新資訊 Latest guidelines on bevacizumab(Avastin®)

         Bevacizumab(Avastin®)為一用於治療多種癌症的抗腫瘤藥物, 美國食物及藥物管理局(USFDA)與歐盟藥物管理局(EMA)近期發出了關於Avastin®用於乳癌的處方指引:

  • USFDA建議取消Avastin®用於治療乳癌病人的適應症

        USFDA於評估數個有關Avastin®治療乳癌病人的研究後, 認為該藥不會延長病人的生存期或減慢其惡化, 而且病人會出現明顯的嚴重不良反應, 當中包括嚴重高血壓﹑出血﹑鼻﹑胃部或腸道穿孔﹑心臟病發和心力衰竭等。根據目前有關使用Avastin®治療轉移性乳癌的資料, USFDA認為使用該藥的風險高於其效益。對於正在使用Avastin®治療轉移性乳癌病人的腫瘤科醫生, 應根據具體臨床情況, 以決定病人應否繼續使用該藥治療, 或改用其他適合的治療方案。

  • EMA確認併用Avastin®paclitaxol治療乳癌病人的好處大於風險

       EMA指現在數據顯示, Avastin®併用paclitaxol治療轉移性乳癌病人, 可延長病人的存活期和提高其生存率, 因此確認其效益高於風險, 並肯定其治療價值然而, EMA並不建議Avastin®docetaxel/capecitabine併用。EMA建議腫瘤科醫生:

      1. 對於治療效果良好的乳癌病人, 應繼續併用Avastin®paclitaxel作為治療方案

      2. 停止併用Avastin®docetaxel/capecitabine治療轉移性乳癌病人。

 

綜合上述, 藥物監測暨管理處建議腫瘤科醫生在使用Avastin®治療轉移性乳癌病人時, 應評估每個病人的風險-效益情況, 並作出適當決定

                                                                                                                                                     

        Bevacizumab(Avastin®) is an anticancer medicine. Latest guidelines from United States Food and Drug Administration (USFDA) and European Medicines Agency (EMA) indicated new advices on patients with breast cancer

  • USFDA recommends removing the breast cancer indication for Avastin®

        After reviewing several studys about breast cancer patients using Avastin®, USFDA determined that Avastin® neither prolong patients’ overall survival nor slow down their disease progression. Moreover, patients experienced an increase in toxicity, which were reflected as a significant increase in side effects namely severe high blood pressure, bleeding and hemorrhage, development of nasal, gastro or intestinal perforations, heart attack or heart failure. On the basis of all available data relating to the use of Avastin® to treat metastatic breast cancer, the agency has determined that the risks of the drug outweigh the benefits for this use. Oncologists currently treating patients with Avastin® for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.

  • EMA confirmed concomitant use of Avastin® and paclitaxol

        Available data indicated Avastin® with paclitaxol in patients with metastasized breast cancer clearly prolonged survival free of disease progression and overall survival without prejudice.  This combination, therefore, continues to be a valid therapeutic option as the benefit exceeded the risk. EMA negated the concurrent uses of bevacizumab with docetaxel/capecitabine. Advice for the physicians:

   1. continue using Avastin® and paclitaxel as a combination treatment of metastatic breast cancer and maintain current treatment modalities on patients who are responding well;

   2. discontinue therapies combining Avastin® with docetaxel/capecitabine for patients with metastatic breast cancer.

 

In view light of above, Division of Pharmacovigilance and Pharmacoeconomics recommends that oncologists treating patients with metastatic breast cancer evaluate individuals of risk and benefit to decide whether to use Avastin®.

  

參考資料/References and websites:

https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM237171.pdf

https://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/12/news_detail_001166.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1


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